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临床试验/NCT04536103
NCT04536103招募中不适用

Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry

Xiaojuan Li1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
88
试验地点
1
主要终点
Knee MRI

研究概览

简要总结

Currently the diagnosis of OA is based on radiographs and clinical findings, which is limited to detecting late-stage disease. There is a pressing, unmet clinical need for robust assessment of early changes in cartilage health. Towards this goal, extensive efforts are ongoing to develop quantitative MRI for cartilage matrix analysis. MR T1ρ and T2 relaxation times have shown to be promising imaging biomarkers for early cartilage degeneration and prediction of disease progression. However, many challenges remain to clinically applying these techniques, including lack of standardized acquisition and quantification methods, and long acquisition times. The study aims to develop novel, fast and reproducible MR T1ρ and T2 relaxation time imaging methods on MR systems from multiple vendors and establish a platform for standardization and cross validation of these measures as a tool for clinical trials using such techniques. Following method validation, patients at risk for osteoarthritis will be tested.

详细描述

The significance of this study is twofold. First, one typical hurdle in applying advanced quantitative MRI to clinical protocols is the long acquisition time. The proposed novel acceleration techniques will facilitate clinical translations of T1ρ and T2 imaging by reducing the time and cost to integrate the sequences into standard clinical practice, increasing patient comfortableness and reducing potential motion artifacts. Second, it is an essential but sometimes overlooked step to investigate quantification variability across sites and MR systems in order to validate MR imaging biomarkers and to apply the measures in large scale multi-vendor multi-site trials. Specifically, there is a lack of systematic evaluation of inter-vendor inter-site variability of T1ρ imaging even though it has been widely applied in neural imaging, liver imaging, cardiac imaging, oncology imaging, and musculoskeletal imaging. Furthermore, no commercial T1ρ phantoms are available with validated reference values. The proposed study is addressing these significant gaps. By implementing and cross-validating T1ρ and T2 imaging on MR systems from different vendors, the outcomes from the proposed study (dedicated calibration phantoms, fast and standardized acquisition and analysis protocols) will provide the field with essential tools for future multi-vendor multi-site trials that will use these quantitative imaging techniques. In this proposal, the innovation and development in patients at risk for osteoarthritis will be tested.

In this study, novel accelerated T1ρ and T2 imaging methods will be developed to systematically evaluate inter-vendor inter-site variation of these measures using dedicated T1ρ and T2 calibration phantoms (to be developed in this study) and traveling subjects, and demonstrate the feasibility in patients after ACL injury and reconstruction who are at risk of post-traumatic OA. The investigation has three Specific Aims:

    • Develop novel acceleration techniques for fast 3D T1ρ and T2 imaging. Despite the increasing availability of accelerated morphologic imaging using compressed sensing (CS) techniques, applications of CS to quantitative MRI are still very limited with the challenges of maintaining quantitative accuracy. A novel convex, model-based CS technique will be developed to take full advantage of the known model for T1ρ and T2 decay.
    • Develop a calibration phantom suitable for standardization of T1ρ and T2 measurements and implement acceleration techniques on MR systems of three major vendors (Siemens, GE and Philips). The phantom development and reference measurements will be in collaboration with the National Institute of Standards and Technology (NIST). The accelerated T1ρ and T2 sequences will be implemented on six MR systems at four sites from three vendors. Inter-site and inter-vendor variation of T1ρ and T2 will be quantified in phantoms and traveling human subjects.
    • Demonstrate the ability of the newly developed acceleration techniques to quantify cartilage degeneration longitudinally in a multi-vendor setting. Subjects with acute anterior cruciate ligament (ACL) tears, an established 'early OA' model, along with age-, gender-, and BMI-matched controls will be scanned on three MR systems using standard and accelerated T1ρ and T2 protocols at baseline and one-year. A novel atlas-based voxel-based relaxometry (VBR) analysis will be applied. Cross-sectional and longitudinal measures will be compared between standard and accelerated T1ρ and T2 protocols.

Four groups of subjects will be recruited at CCF for the study.

Group I: 30 volunteers (for Aim 1) The 30 volunteers from Group I will be recruited at CCF for evaluating differences between standard T1rho and T2 imaging vs accelerated T1rho and T2 imaging techniques that will be developed from this study.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Sustain an acute full ACL tear in one knee; the contralateral knee uninjured
  • Undergo ACL reconstructions and standard rehabilitation

排除标准

  • Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
  • Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
  • History of osteoarthritis and inflammatory arthritis
  • Previous injury and/or surgery on either knee
  • Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
  • Inability to undergo standard pre- and post-injury/operative rehabilitation
  • Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
  • History of osteoarthritis and inflammatory arthritis
  • Previous injury and/or surgery on either knee

结局指标

主要结局

Knee MRI

时间窗: Year 1-2

Knee MRI will be collected at the 3T scanner (Prisma) at CCF. One time point. The MRI exam time will be two hours per subject including set up. No questionnaires will be required.

ACL tear and reconstruction

时间窗: Year 3-5

Knee MRI at three 3T scanners at CCF (Siemens, GE, Philips). For patients, the ACL injured and reconstructed knee will be scanned. For controls, to scan which side of the knee (left or right) will be based on subjects' preference. If the subject has no reference, the dominant leg will be scanned. At each time point, the three scans can be on the same day or on different days, but all the three scans need to take place within 2 weeks to minimize potential physiologic variations. For patients with ACL tear and reconstruction, surgical report (including graft type, surgeon recorded lesions) will also be collected.

Site reproducibility

时间窗: Year 2-3

Knee MRI will be collected at three 3T scanners at CCF (Siemens, GE, Philips), and three scanners at UCSF, University of Kentucky and Albert Einstein College of Medicine, respectively. The three scans at CCF can be on the same day or on different days, but all six scans need to take place within 2 months to minimize potential physiologic variations.To evaluate the reproducibility, subjects will be scanned and then rescanned during one visit on the same day for each of the six scans.

次要结局

  • Site reproducibility with patient outcomes and knee health(Year 2-3)
  • ACL tear and reconstruction with patient outcomes and knee health(Year 3-5)

研究者

发起方
Xiaojuan Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiaojuan Li

PI

The Cleveland Clinic

研究点 (1)

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